The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3
4 months of assistance tailored to the needs of the participant
Referral to United Way 2-1-1
Washington University School of Medicine
St Louis, Missouri, United States
Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit
Time frame: 6 weeks after enrollment
Total number of unmet basic needs
-Unmet basic needs include food security, housing, personal safety, neighborhood safety, sufficient money for necessities, childcare (if applicable), and transportation. A questionnaire will be given to participants to identify the number of unmet basic needs the participant has.
Time frame: 4 months after enrollment
Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List
Participants will be asked to rate the amount of distress (scale of 0 to 10, 10=extreme distress) that they have experienced in the past week and the amount of distress (scale of 0 to 10) that they attribute to their abnormal cervical cancer screen. The NCCN distress problem list is a 40-item list categorized into five themes-practical, family, emotional, spiritual, and physical problems¬-and leaves room for patients to describe "other".
Time frame: Enrollment and 4 months after enrollment
Intent to use intervention over time
-Providers are asked after completion of enrollment to indicate on a scale of 1=not committed to 10=fully committed of how committed they are to use the intervention in their clinic.
Time frame: Completion of study enrollment (estimated to be 18 months)
Patients' satisfaction with intervention
-The interview guide has two questions that relate to patient satisfaction related to the intervention. 1) Was the \[community health worker or 2-1-1 operator\] helpful to you? 2) Would you recommend \[the community healthworker/2-1-1\] to a family member or friend?
Time frame: Completion of study enrollment (estimated to be 18 months)
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Providers' satisfaction with intervention
-Providers are asked after completion of enrollment to indicate their satisfaction with the intervention. They are given 12 statements about the satisfaction of the intervention and are asked to circle responses of 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, or 5=completely agree. The higher the score the more satisfied the provider is with the intervention.
Time frame: Completion of study enrollment (estimated to be 18 months)
Resources needed to sustain intervention
-Validated questionnaire that will be administered to providers, staff, and community health workers: Self-administered 15-minute online survey that will be completed at the end of the study enrollment period. The survey will ask about specific implementation outcomes using the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure.
Time frame: Completion of study enrollment (estimated to be 18 months)
Likelihood that intervention will become built into usual care
-Providers are asked after completion of enrollment to indicate the likelihood that the intervention can be built into usual care in their clinic. The responses are either likely, very likely, neutral, unlikely, very unlikely, or unsure.
Time frame: Completion of study enrollment (estimated to be 18 months)